Clinical Trial

A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

Recruiting Phase 1/2
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Summary
This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \[18F\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission. The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by \[18F\]DOPA Kicer (\[18F\]DOPA relative uptake rate)).
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-10
Trial Details
NCT Number NCT07423546
Lead Sponsor New York State Psychiatric Institute
Collaborators: Bristol-Myers Squibb
Conditions SCHIZOPHRENIA 1 (Disorder), Schizoaffecitve Disorder
Enrollment 12 participants
Start Date 2026-07-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-14